CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2016.
Mark Perrin, InVivo’s CEO and Chairman, said, “2016 was a year marked by meaningful and significant progress. In 2016, we:
- received approval for converting the Neuro-Spinal Scaffold™ pilot study to the pivotal INSPIRE study;
- received approval to initiate the INSPIRE study in Canada (1st global step for InVivo);
- added 13 new clinical sites, including our first ex-U.S. sites (both in Canada);
- enrolled seven new patients, with three of those patients achieving the primary endpoint of conversion to partial paralysis by six months post-injury1;
- continued our spinal cord injury (SCI) thought leadership by attending and presenting at international conferences, where we presented 13 scientific abstracts to renowned leaders within the neurosurgical, neuroscience, and SCI communities;
- raised $32 million (gross), which is the company’s largest fund raising to date;
- successfully developed a preclinical prototype of the TrailMaker™ for the chronic spinal cord injury market and filed two patent applications;
- garnered unique media coverage about InVivo and the Neuro-Spinal Scaffold in 18 widely-read outlets resulting in nearly 30 million media impressions;
- and continued to make great strides in strengthening our research and intellectual property portfolio.
We ended the year with approximately $33 million in cash, cash equivalents, and marketable securities that we project will fund us into the second quarter of 2018, by which time we expect to be able to submit the HDE application for marketing approval of the Neuro-Spinal Scaffold. Over the coming quarters, we will continue to make progress toward this goal by enrolling more patients, increasing sites, expanding into the U.K., and completing enrollment of the INSPIRE study, which we are now projecting will occur in the third quarter of 2017.
In addition to the progress with INSPIRE, we also plan to initiate our first study in cervical SCI in Canada in the coming months. Cervical SCI represents a higher risk, higher reward indication in which the effects of neural preservation, regeneration or remyelination may be more dramatically demonstrated. I am excited at the prospect of building upon last year’s advances and continuing our journey to redefine the lives of patients with spinal cord injuries.”
For the year ended December 31, 2016, the Company reported a net loss of approximately $23,438,000, or $0.76 per share, compared to a net loss of approximately $33,314,000, or $1.26 per share, for the year ended December 31, 2015. Included in results for the years ended December 31, 2016 and 2015 were non-cash gain of $593,000 and a non-cash loss of $10,804,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the year ended December 31, 2016, was $24,031,000, or $0.78 per share, compared to an adjusted net loss of $22,510,000, or $0.85 per share, for the year ended December 31, 2015. The Company ended the year with $33,041,000 of cash, cash equivalents, and marketable securities as of December 31, 2016.
Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the items noted. A reconciliation of these measures to the comparable GAAP measures is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors, enabling them to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding these identified items.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with thoracic complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as "believe," "anticipate," "intend," "estimate," "will," "may," "should," "expect" and similar expressions, and include statements regarding expected enrollment in its pivotal INSPIRE study in 2017, expansion of clinical sites into the UK and Canada, initiation of a cervical spinal cord injury study, and the benefits of the Neuro-Spinal Scaffold.. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the Company’s ability to obtain FDA approval to commercialize its products; the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology in connection with spinal cord injuries; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, and its other filings with the SEC, including the Company’s Form 10-Qs and current reports on Form 8-K. The Company does not undertake to update these forward-looking statements.
InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
(In thousands, except share and per-share data)
|Cash and cash equivalents||$21,464||$14,920|
|Prepaid expenses and other current assets||451||184|
|Total current assets||33,853||20,739|
|Property, equipment and leasehold improvements, net||510||938|
|LIABILITIES AND STOCKHOLDERS’ EQUITY:|
|Loan payable, current portion||423||395|
|Derivative warrant liability||1,314||1,907|
|Deferred rent, current portion||141||115|
|Total current liabilities||4,848||3,312|
|Loan payable, net of current portion||852||1,275|
|Deferred rent, net current portion||135||276|
|Commitments and contingencies|
|Common stock, $0.00001 par value, authorized—100,000,000 shares, issued and outstanding 32,044,087 shares at December 31, 2016; and authorized 50,000,000 shares, issued and outstanding 27,555,948 shares at December 31, 2015||1||1|
|Additional paid-in capital||185,955||150,497|
|Total stockholders’ equity||28,949||16,929|
|Total liabilities and stockholders’ equity||$34,784||$21,792|
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations
(In thousands, except share and per-share data)
|Years Ended December 31,|
|Research and development||$12,557||$10,058||$10,273|
|General and administrative||11,506||12,340||7,566|
|Total operating expenses||24,063||22,398||17,839|
|Other income (expense):|
|Derivatives gain (loss)||593||(10,804)||(376)|
|Other income (expense), net||625||(10,916)||(507)|
|Net loss per share, basic and diluted||$(0.76)||$(1.26)||$(0.83)|
|Weighted average number of common shares outstanding, basic and diluted||31,025,585||26,461,374||22,080,761|
|Reconciliation of GAAP to non-GAAP measures|
|InVivo Therapeutics Holdings Corp.|
|(In thousands, except share and per share data)|
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Reported GAAP net income (loss)||(5,435||)||(4,733||)||(23,438||)||(33,314||)|
|Adjusted net loss||(6,816||)||(5,277||)||(24,031||)||(22,510||)|
|Reported GAAP net loss per diluted share||(0.17||)||(0.17||)||(0.76||)||(1.26||)|
|Derivative (gain)/loss per diluted share||(0.04||)||(0.02||)||(0.02||)||0.41|
|Adjusted net loss per diluted share||(0.21||)||(0.19||)||(0.78||)||(0.85||)|
1 two patients passed away and one unconverted patient has less than six months of follow-up.